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Episodic Cluster HeadachePhase 3NCT02797951

A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

A Phase 3 study testing Galcanezumab in people with Episodic Cluster Headache and Chronic Cluster Headache, run by Eli Lilly and Company at 40 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Galcanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
40 sitesin 12 countries
Study dates
13 Jul 2016to 21 Jan 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who participated in and completed either study CGAL or study CGAM.
  • Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.

Who cannot join

  • Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM).
  • Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF) (with the exception of Study CGAL or Study CGAM).
  • A history of migraine variants that could implicate or could be confused with ischemia.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
  • A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
  • Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
  • Women who are pregnant or nursing.

Trial locations and contacts

40 sites in 12 countries.

40 sites in 12 countries

United States11 sites

  • Michigan Head, Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007-4209

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Stanford University Hospital

    Palo Alto, California, 94304

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

France5 sites

  • CHRU de Lille - Hôpital Roger Salengro

    Lille, Cedex, 59037

  • APHM Hôpital de la Timone

    Marseille, 13385

  • Hôpital de Cimiez

    Nice, 06000

  • Hopital Lariboisière

    Paris, 75475

  • CHU St Etienne Hopital Nord

    Saint-Etienne, 42000

Other trials in France

Germany5 sites

  • Praxis Dr. Philipp Stude

    Bochum, North Rhine-Westphalia, 44787

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Migräne- und Kopfschmerzklinik GmbH & Co. KG

    Königstein im Taunus, Hesse, 61462

  • Klinikum der Universität München

    München, Bavaria, 81377

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50139

  • Istituto Neurologico Carlo Besta

    Milan, 20133

  • Fondazione Istituto Neurologico Nationale C. Mondino

    Pavia, 27100

Other trials in Italy

United Kingdom3 sites

  • Hull Royal Infirmary

    Hull, East Yorkshire, HU3 2JZ

  • Walton Centre for Neurology and Neurosurgery

    Liverpool, Lancashire, L9 7LJ

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG

Other trials in United Kingdom

Belgium2 sites

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • Centre Hospitalier Regional de la Citadelle

    Liège, 4000

Other trials in Belgium

Canada2 sites

  • Centre de Traitement Neurologique

    Montreal, H2W 1V1

  • Stroyan Research

    Toronto, Ontario, M4S 1Y2

Other trials in Canada

Finland2 sites

  • Suomen Terveystalo

    Jyväskylä, 40100

  • Terveystalo Pulssi

    Turku, 20100

Other trials in Finland

Greece2 sites

  • 401 Army General Hospital of Athens

    Athens, Attica, 11525

  • Eginition Hospital of Athens

    Athens, 11528

Other trials in Greece

Netherlands2 sites

  • Boerhaave Medisch Centrum

    Amsterdam, 1078 VV

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

Other trials in Netherlands

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Denmark1 site

  • Glostrup Hospital

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

Official title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).

Being tested
Galcanezumab
Keywords
cluster headache, headache, brain diseases, central nervous system diseases, headache disorders, headache disorders, primary, nervous system diseases, neurologic manifestations, pain, trigeminal autonomic cephalalgias
Medical subject headings
Cluster Headache, Headache, Brain Diseases, Central Nervous System Diseases, Headache Disorders, Headache Disorders, Primary, Nervous System Diseases, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalcanezumabDrug

    Also called LY2951742

    Administered SC

Study groups in NCT02797951
Study groupRoleWhat they receive
GalcanezumabExperimentalParticipants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
Receives: Drug: Galcanezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

    A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase.

    An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.

    Measured: Baseline through End of Study (Up to 4 Years)

  2. Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)

    C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).

    • Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.
    • Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.

    Measured: Baseline through End of Study (Up to 4 Years)

Secondary outcomes (1)

  1. Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab

    A participant is considered TE-ADA positive if:

    • ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or
    • ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).

    Measured: Baseline through End of Study (Up to 4 Years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study start13 Jul 2016
  3. Primary completion21 Jan 2021
  4. Study completion21 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02797951
Sponsor's protocol ID
16351
Other IDs
I5Q-MC-CGAR, 2015-005234-21, 2015
Status last verified
Jan 2022
First submitted
9 Jun 2016
Last updated
10 Feb 2022
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.

    PubMed 35633025

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galcanezumab in people with Episodic Cluster Headache and Chronic Cluster Headache, run by Eli Lilly and Company at 40 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, France, Germany, Italy, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) (time frame: Baseline through End of Study (Up to 4 Years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02797951, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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